About this trial
In Belgium, labour epidural analgesia (LEA) has been used for decades in the vast majority of vaginal deliveries (up to 83% of deliveries). Labour epidural analgesia is the most effective and safest way to allow pregnant women a nearly pain-free labour- and birth experience. Recent data showed that the use of LEA was associated with a reduced risk for severe maternal morbidity, neonatal resuscitation and with a reduced risk for low Apgar scores. However, prenatal exposure to labour epidural analgesia has been associated by several study groups with an increased risk for autism spectrum disorder (ASD) in the children, but these studies suffer from several important limitations which may have induced significant bias (e.g., not correcting for unmeasured confounders). Associations with other neurodevelopmental disorders (e.g., Attention Deficit Hyperactivity Disorder (ADHD), oppositional defiant disorder (ODD) and conduct disorder (CD)) and cognitive functioning have not been investigated yet. There is hence an urgent need for a study allowing definitive conclusions by overcoming the limitations of the previous studies. The investigators will perform the first sibling-matched clinical cohort study using a prospective investigator-assessment of multiple domains of cognitive functions. The investigators hypothesize that prenatal exposure to LEA will neither be associated with reduced intelligence nor with more neurodevelopmental disorders. Validating this hypothesis holds the potential to grant women the assurance to confidently receive the most efficacious method for labour analgesia, free from apprehension that it might have adverse implications for their children's neurodevelopment.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Exposed children: Children prenatally exposed to labour epidural analgesia
Unexposed children: Sibling of an exposed child, Prenatally not exposed to labour epidural analgesia
Exposed & unexposed children: Children born from 1st January 2014 until 1st November 2019, Parental informed consent
Disqualifiers
Children whose mothers underwent maternal surgery or foetal surgery/interventions during the same pregnancy.
Children exposed to general anaesthesia after birth
Children prenatally exposed to chemotherapy, radiotherapy, radiology, oncologic pathology
Children born at a gestational age < 37 weeks or > 42 weeks, or with a birth weight < 2.5 kg
Trial population
Sibling pairs discordant for prenatal exposure to labour epidural analgesia will be included
Trial design
Cohort
Other
Treatments tested in this trial
Labour epidural analgesia
Procedure/SurgeryPrenatal exposure to labour epidural analgesia during delivery
Treatment groups
Trial outcomes
Primary outcomes
Wechsler full-scale intelligence quotient
Will be assessed using the Wechsler Intelligence Scale for Children (WISC). Minimum value: 40, maximum value: 160. Higher scores mean a better outcome.
Secondary outcomes
Indices of the Wechsler intelligence scale
Verbal comprehension, working memory, visual spatial, fluid reasoning, processing speed. Minimum value: 40, maximum value: 160. Higher scores mean a better outcome.
Clinically relevantly decreased intelligence quotient
The absolute risk reduction for a clinically relevantly decreased intelligence quotient, defined as an IQ\<85, will be calculated.
Social responsiveness scale (SRS)
Parental reported social deficits in the autism spectrum. Minimum value: 0, maximum value: 195. Higher scores represent a worse outcome.
Disruptive Behavior Disorders Rating Scale (DBDRS)
Parental reported traits of inattention, hyperactivity and impulsivity (ADHD), oppositional defiant disorder (ODD) and conduct disorder (CD). Minimum value: 0, maximum value: 135. Higher scores mean a worse outcome.
Sponsors and contacts
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